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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00642902




Registration number
NCT00642902
Ethics application status
Date submitted
21/03/2008
Date registered
25/03/2008
Date last updated
24/05/2016

Titles & IDs
Public title
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
Scientific title
A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course
Secondary ID [1] 0 0
28063
Universal Trial Number (UTN)
Trial acronym
ATAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atacicept
Treatment: Drugs - Atacicept
Treatment: Drugs - Atacicept
Treatment: Drugs - Placebo matched to atacicept

Experimental: Atacicept 25 mg -

Experimental: Atacicept 75 mg -

Experimental: Atacicept 150 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.

Treatment: Drugs: Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.

Treatment: Drugs: Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Treatment: Drugs: Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
Timepoint [1] 0 0
Weeks 12 to 36
Secondary outcome [1] 0 0
Number of New T1 Gd-enhancing Lesions Per Participant
Timepoint [1] 0 0
Weeks 12, 24, 36
Secondary outcome [2] 0 0
Percentage of Participants Free From Relapses
Timepoint [2] 0 0
Baseline up to Week 36
Secondary outcome [3] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Timepoint [3] 0 0
From the first dose of study drug administration up to 12 weeks after the last dose of the study drug

Eligibility
Key inclusion criteria
- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have primary progressive multiple sclerosis (MS)
* Have secondary progressive MS without superimposed relapses
* Relevant cardiac, hepatic and renal diseases as specified in the protocol
* Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
* Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment hospital [3] 0 0
Research Site - New Lambton
Recruitment hospital [4] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- New Lambton
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Belgium
State/province [10] 0 0
Diepenbeek
Country [11] 0 0
Belgium
State/province [11] 0 0
Sijsele
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Hradec Kralove
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Olomouc
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Saint-Herblain
Country [19] 0 0
Germany
State/province [19] 0 0
Bochum
Country [20] 0 0
Germany
State/province [20] 0 0
Dusseldorf
Country [21] 0 0
Lebanon
State/province [21] 0 0
Beirut
Country [22] 0 0
Lebanon
State/province [22] 0 0
Beyrouth
Country [23] 0 0
Lithuania
State/province [23] 0 0
Kaunas
Country [24] 0 0
Netherlands
State/province [24] 0 0
Breda
Country [25] 0 0
Netherlands
State/province [25] 0 0
Nieuwegein
Country [26] 0 0
Netherlands
State/province [26] 0 0
Rotterdam
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Dnipropetrovsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Ekaterinburg
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Novosibirsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Saint Petersburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Samara
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Vladimir
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Yaroslavl
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Malaga
Country [38] 0 0
Sweden
State/province [38] 0 0
Stockholm
Country [39] 0 0
Switzerland
State/province [39] 0 0
Basel
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kharkiv
Country [41] 0 0
Ukraine
State/province [41] 0 0
Kyiv
Country [42] 0 0
Ukraine
State/province [42] 0 0
Odessa
Country [43] 0 0
Ukraine
State/province [43] 0 0
Uzhgorod
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Sheffield
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00642902